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Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)

Award Number: U01CA233169
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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Project Summary EVOLV proposes to deliver sophisticated and standardized methods for assessing, monitoring, analyzing, and reporting adverse events (AEs) experienced by individuals undergoing cancer treatment. These methods will harness the potential of the patient-reported outcomes version of the NCI Common Terminology Criteria for Adverse Events (PRO-CTCAETM) to provide previously unavailable patient perspectives on the tolerability of treatments (including targeted agents, immunotherapies, and other evolving treatments for which the type, severity, timing, and trajectory of adverse events is less known). Such information will help providers better identify and support patients at risk for treatment discontinuation, dose reductions, and treatment delays. Specifically, this study aims to: 1) perform longitudinal analyses of CTCAE and PRO-CTCAE data from trials conducted within the ECOG-ACRIN Cancer Research Group, using traditional and innovative strategies to examine AE trajectories and to produce a new reporting standard that reflects severity and fluctuations over time; 2) examine PRO-CTCAE and CTCAE predictors of treatment adherence and discontinuation; and 3) validate the broader predictive value of GP5, a single item from the Functional Assessment of Cancer Therapy- General (FACT-G) shown to predict early treatment discontinuation among women with breast cancer taking aromatase inhibitors. The study will also explore two novel measurement models for PRO-CTCAE scores and CTCAE grades: a phenotypic model including co-occurrence of symptoms and a cumulative burden index (CBI) for characterizing the quantity of burden accumulated by patients over time. Analyses will include demographic factors and insurance status to identify potential disparities.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $350,000 )
2023	2023	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/16/2023	SUPPLEMENT FOR EXPANSION	$350,000
2023	2022	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	5	4/27/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $350,000

Issue Date FY: 2022 ( Subtotal = $614,234 )
2022	2022	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/23/2022	NON-COMPETING CONTINUATION	$614,234
2022	2021	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	3/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $614,234

Issue Date FY: 2021 ( Subtotal = $589,450 )
2021	2021	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	4	8/20/2021	NON-COMPETING CONTINUATION	$589,450
2021	2020	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	3/26/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $589,450

Issue Date FY: 2020 ( Subtotal = $618,498 )
2020	2020	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	3	8/17/2020	NON-COMPETING CONTINUATION	$618,498
2020	2019	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	4/2/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $618,498

Issue Date FY: 2019 ( Subtotal = $533,791 )
2019	2019	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	2	8/15/2019	NON-COMPETING CONTINUATION	$533,791
2019	2018	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	11/1/2018	NEW	$0
														Subtotal = $533,791

Issue Date FY: 2018 ( Subtotal = $701,440 )
2018	2018	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/18/2018	NEW	$701,440
														Subtotal = $701,440

Grand Total All Awards = $3,407,413

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Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)

Award Number: U01CA233169

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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